Medical Devices (MDD), In Vitro Diagnostic Devices (IVDD),
EC REP & CE Mark
(Medical Device Directive 93/42/EEC, Active Implantable Medical Devices 90/385/EEC and In Vitro Diagnostic Medical Device Directive 98/79/EEC).
MDSS pioneered European Representation and is well known and respected with Competent Authorities, which enables us to achieve the best solutions with your interests in mind. We handle sensitive tasks with the Competent Authority with integrity and perfection.
Our AR Services (Authorized Representative Services) encompass the entire range of Authorized Representative Services designed to help your business thrive in these turbulent times:
- National Registration
- Free Sales Certificate /Certificate of Marketability
- Clinical Evaluation
- CE Mark Services
- European Community Representative Services (EC Rep)
Caution: Due to the rapid changes of the European regulation, the MDSS website may not be up-to-date with its information in all areas.
Therefore, always refer to the Commission website (please click and you will be automatically directed to our link section) and/or any national website for the latest regulation news.
You may consult our News & Views section for the most frequently asked questions. To get advice on a particular aspect please contact MDSS directly.